MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX05RW

Device Problem Increase in Pressure (1491)

Patient Problem Blood Loss (2597)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Visual inspection upon receipt revealed no defects.The oxygenator module was rinsed by letting physiological saline solution flow through it by gravity.Subsequent visual inspection found the presence of clots formed inside the device.Physiological saline solution was filled and circulated in the oxygenator module and the pressure drop was determined at each flow rate.The obtained values were found to be higher than those of the current product sample.The actual device was fixed with glutaraldehyde solution and the housing component and filter were removed from the oxygenator module.Visual inspection of the filter removed from the oxygenator module found the formation of clots on the outer and inner surfaces.Visual inspection of the oxygenator module, after the housing component and filter having been removed from it, found the formation of clots.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.Clots were found to have formed there.There was no anomaly in the state of fiber winding.The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections.The formation of clots was found on it.Magnifying inspection of the both sides of the filter removed from the oxygenator module in the above revealed the formation of red thrombus on them.There was no anomaly in the diameter of the mesh of the filter.Magnifying inspection of the fiber layers removed from the oxygenator module in the above revealed the formation of clots on them.Electron microscopic inspection of the outer and inner surfaces of the filter removed from the oxygenator module revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells and blood platelets, to them.Electron microscopic inspection of the upper segments of the fiber layers removed from the oxygenator module above revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells (echinocytes) and blood platelets, to them.The clots adhering to the surface of the bottom area of the heat exchanger were sampled and inspected under electron microscope.The presence of blood corpuscle components, including deformed red blood cells and the formation of fibrin net were revealed.There is no evidence that this event was related to a device defect or malfunction.During the above investigation, the formation of clots was found on the filters, fibers and heat exchanger housed inside the actual oxygenator module.Electron microscopic inspection of the clots revealed the formation of fibrin nets on it and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells(echinocytes) and blood platelets, to it.In this case, it is likely that the clots formed due to some factor(s) resulted in the increase in the pressure.From the investigation of the actual device, however, it is difficult to definitively determine the cause of the formation of clots.A review of the device history record of the involved product code/lot number combination revealed no findings.A search of the complaint file found no other report of this nature with the involved product code/lot# combination.The ifu states: "adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur." (b)(4).

Event Description

The user facility reported a pressure increase on the involved capiox device.Around 4 minutes after the initiation of the extracorporeal circulation, the pressure increased.The actual sample was changed out.The amount of blood loss was reported to be unknown.The procedure outcome is unknown.Final patient condition is unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 7734680
• MDR Text Key: 115537774
• Report Number: 9681834-2018-00142
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 180308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other